Medical access sheath

• US 20060041270A1
• Filed: 05/09/2005
• Published: 02/23/2006
• Est. Priority Date: 05/07/2004
• Status: Abandoned Application

• Current Assignee: Onset Medical Corp. (Terumo Corporation)
• Original Assignee: Onset Medical Corp. (Terumo Corporation)
• Inventors: Nance, Edward J., Lenker, Jay, Tchulluian, Onnik
• Application Number:
  US11/124,903
• Publication Number:
  US 20060041270A1
• Time in Patent Office: Days
• US Class Current: 606/198
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

An expandable sheath is insertable into a patient through an incision. Once inserted and advanced to the target surgical site, the sheath can be expanded to an enlarged diameter. The wall of the sheath is fabricated from a tubular structure comprising filamentous elements that extend axially and at least partially circumferentially along the length of the sheath. The tubular filamentous material is drawn or expanded axially to create the small diameter configuration that is inserted into the patient. A standoff attaches the distal end of the tubular filamentous material to the sheath hub by way of radially movable anchors. Additional filamentous tubular material extends out the proximal end of the hub. A compression mechanism forces the additional filamentous tubular material in the distal direction which causes axial compression and radial or diametric dilation of the working length of the sheath, that part of the sheath that extends beyond the proximal end of the hub. Radial dilation is accomplished with no substantial change in sheath working length.

Claims

1. An access sheath for expanding an opening in biological tissue from a first cross-sectional area to a second larger cross-sectional area, the sheath comprising:

a hub having a distal end and a proximal end and an opening extending therethrough;

a substantially tubular mesh extending through the hub and comprising a distal portion that extends from the distal end of the hub and a proximal portion that extends proximally from the proximal end of the hub;

a radially expandable standoff that extends distally from the hub and is coupled to a distal portion of the mesh and to the hub; and

a compression mechanism configured to advance the proximal portion of the mesh distally towards the hub causing axial compression and diametrical expansion of the mesh.

2. The sheath of claim 1, further comprising a containment layer that is substantially impermeable to liquids and is coupled to the mesh.

3. The sheath of claim 2, wherein the containment layer is disposed on the exterior of the mesh.

4. The sheath of claim 1, further comprising a seal hub that is coupled to the proximal portion of the mesh.

5. The apparatus of claim 4, further comprising a lock configured to selectively couple the seal hub to the hub.

6. The sheath of claim 4, further comprising a telescoping member extending between the seal hub and the proximal end of the hub.

7. The sheath of claim 4. further comprising a slide member extending between the seal hub and the proximal end of the hub.

8. The sheath of claim 4, wherein the seal hub is configured be disconnected from the hub and withdrawn proximally to allow the distal portion of the mesh to become smaller in diameter.

9. The sheath of claim 1, wherein the compression mechanism comprises a pinch roller mechanism.

10. The apparatus of claim 1, wherein the mesh is configured to be advanced distally by a shape memory transition from a martensitic to an austenitic state.

11. The sheath of claim 1, further comprising an obturator that extends through the mesh.

12. The sheath of claim 1 wherein the mesh and the at least one standoff are configured to bend.

13. A method of providing access to a surgical site;

comprising;

inserting a sheath, which comprises a hub and an expandable tubular member that extends through the hub, into an incision;

advancing a distal portion of the tubular member to a target depth; and

expanding the distal portion of the tubular member diametrically while simultaneously advancing a proximal portion of the tubular member distally toward the hub.

14. The method of claim 13, further comprising inserting an obturator into the incision along with the sheath.

15. The method of claim 13, further comprising the step of inserting the sheath and an obturator over a guidewire.

16. The method of claim 13, further comprising inserting at least one instrument through a lumen of the sheath.

17. The method of claim 13, further comprising reducing the diameter of the sheath and thereafter removing the sheath from the patient.

18. A surgical access device for expanding an opening in a patient, comprising:

a hub having a distal end and a proximal end and an opening extending therethrough;

a radially expandable tubular body comprising a distal portion that extends distally of the hub, a proximal portion that extends proximally of the hub, and an axial lumen therethrough; and

means for applying an axially compressive force to the tubular body to reversibly expand the axial lumen from a first, smaller, diameter to a second, larger diameter, without substantially shortening the axial length of the distal portion of the tubular body.

19. A method of providing access to a surgical site;

comprising;

providing a sheath having a hub and an expandable tubular member comprising a distal portion and a proximal portion, the distal portion extending distally of the hub and the proximal portion extending proximally of the hub;

inserting the distal portion of the tubular member into an incision;

advancing the distal portion of the tubular member to a target depth; and

expanding the distal portion of the tubular member diametrically without substantially changing the axial length of the distal portion with respect to the hub.

20. The method of claim 19, wherein expanding the distal portion of the tubular member further comprises advancing the proximal portion of the tubular member towards the hub.